Biokyra

Wednesday, May 25, 2016

The U.S. Food and Drug Administration (FDA) has
recently released a draft guidance for the 3-D printed medical devices sector.
The agency took into consideration inputs from device manufacturers, 3-D
printing companies, and academics who testified at a 2014 hearing. According toQMED, the document covers
device design, manufacturing, and design testing and for the purposes of the
draft, FDA identified four main types of 3-D printing—powder fusion,
stereolithography, fused filament fabrication, and liquid-based extrusion.

3D printed medical device producers would have to
“clearly identify every step in the 3-D printing process, and might need to
submit a ‘high-level summary of each critical manufacturing process step,’” the
guidance says. They would also have to record each step’s risk, and describe
how they would lessen those risks. “The type of testing data needed would depend
upon whether the device is an implant, load-bearing, and available in standard
sizes or custom-made for each patient, or as FDA put it ‘patient-matched.’”

The implications for 3-D printed devices are enormous
– therefore the draft guidance is the agency’s initial thoughtson the technical
considerations surrounding the design, manufacture and testing of 3-D medical
devices, which have few precedents. “While this draft guidance includes
manufacturing considerations, it is not intended to comprehensively address all
considerations or regulatory requirements to establish a quality system for the
manufacturing of your device,” the agency said.

The draft guidance “provides a solid basis for medtech
innovators to understand what is needed to prove safety, efficacy, and
consistency to growing on-demand components for the human body,” said Derek
Mathers, an adjunct professor of 3-D printing at the University of Minnesota
and business development manager at Worrell Design in Minneapolis.

“Standard-sized
3-D printed devices are offered in discrete sizes, and include features that
are too complex to be manufactured with traditional processes like machining
and molding,” he explained. “Patient-matched 3-D printed devices are devices
that are digitally scaled (manually or by using an algorithm) to match a
patient’s specific anatomical features. The FDA identifies that these bespoke
devices will require significantly more validation work across every step of
the ‘scan-to-fit’ design process.”

Sunday, May 8, 2016

According to a recent report in Kurzweil
Accelerating Intelligence, Samsung Medison has updated its RS80A
ultrasound-imaging machine with a feature called S-Detect for Breast that
analyzes breast lesions. The system uses big data collected from breast-exam
cases and suggests whether the lesion is benign or malignant.

"We saw a high level of conformity
from analyzing and detecting lesion in various cases by using the
S-Detect," said professor Han Boo Kyung, a radiologist at Samsung Medical
Center. "Users can reduce taking unnecessary biopsies and
doctors-in-training will likely have more reliable support in accurately
detecting malignant and suspicious lesions."

Researchers at the Regenstrief Institute
and Indiana University School of Informatics have also noticed that computers
are better than humans in detecting cancer. According to their research,
existing algorithms and open-source, machine-learning tools are as good or even
better than human when detecting cancer cases using data from free-text
pathology reports. The electronic approach was also faster and used fewer
resources than people, according to Regenstreif.

"We think that it’s no longer
necessary for humans to spend time reviewing text reports to determine if
cancer is present or not," said author Shaun Grannis, MD, interim center
director. "We have come to the point in time that technology can handle
this. A human's time is better spent helping other humans by providing them
with better clinical care."